Revision Total Hip ArthroplastyNCT01482533
Tissue Culture Versus Swab Culture in Prosthetic Joint Infections
An observational study of Revision Total Hip Arthroplasty and Revision Total Knee Arthroplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The main purpose of this study is to compare the effectiveness and accuracy of tissue cultures and swab cultures to diagnose prosthetic joint infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Total Hip Arthroplasty, Revision Total Knee Arthroplasty
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing revision surgery for an infection in their knee or hip components.
Who may be able to join
- Patients are scheduled for revision TJA surgery.
- Subjects are willing to sign the informed consent document.
Who cannot join
- 1. Subject not willing to sign the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to compare the effectiveness and accuracy of tissue cultures and swab cultures to diagnose prosthetic joint infection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Revision Total Hip Arthroplasty | Not described | |
| Revision Total Knee Arthroplasty | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany Morrison, MS, Rothman Institute Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482533
- Sponsor's protocol ID
- RIUJPar01-2011
- Status last verified
- Nov 2011
- First submitted
- 28 Nov 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Culture Versus Swab Culture in Prosthetic Joint Infections
- ClinicalTrials.gov ID
- NCT01482533
- Acronym / sponsor ID
- RIUJPar01-2011
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to compare the effectiveness and accuracy of tissue cultures and swab cultures to diagnose prosthetic joint infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revision Total Hip Arthroplasty | – | – |
| Revision Total Knee Arthroplasty | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing revision surgery for an infection in their knee or hip components.
Key inclusion criteria (2 listed)
- Patients are scheduled for revision TJA surgery.
- Subjects are willing to sign the informed consent document.
Key exclusion criteria (1 listed)
- 1. Subject not willing to sign the informed consent document.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision Total Hip Arthroplasty and Revision Total Knee Arthroplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Morrison, MS, CCRP (267-339-7818, tiffany.morrison@rothmaninstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.